Introduction: Implantation of a penile prosthesis may be considered in patients who do not respond to more conservative therapies or prefer a definitive therapy. Inflatable Penile Prosthesis implantation has been associated with high patient satisfaction rates. The aim of this study is to investigate the safety outcomes of the new Infla10® Three-Piece Inflatable Penile Prosthesis (Rigicon, New York) in patients with erectile dysfunction. Methods: 535 patients who underwent Infla10® Three-Piece Inflatable penile prosthesis implantation between 01.06.2019 to 08.04.2022 were included in the study. 103 surgeons from 26 centers participated in the study. All patients were followed up to evaluate the safety of the device. Revision/explantation, and rates of reoperation for infection, mechanical failure, or medical reasons were recorded. SPSS 25.0 (IBM, US) was used for the statistical analysis of the patient demographics and Kaplan Meier survival statistics. Results: The mean follow-up was 24.2 months with a range of 7-36 months. The mean patient age was 56.23 years. The mechanical failure rate was 2.24 %, explantation due to patient dissatisfaction was 0.19 %, Peyronie’s failed correction was 0.19 %, and component out of place was 0.37%, infection rate was 0.19 %. Survival analysis of the device at 12, 24, and 36 months was 96.6%, 97.8%, and 96.8%, respectively, until surgical invention. Conclusions: Early results suggest that Infla10® Three-Piece Inflatable Penile Prosthesis insertion offers comparable safety outcomes in the treatment of patients diagnosed with erectile dysfunction. SOURCE OF Funding: None
